Friday, December 16, 2005
Abortion Pill and Bacterial Infections - Study
New York Times Syndicate
By Diedtra Henderson Globe Staff
Wednesday, November 30, 2005
WASHINGTON - An article in Thursday's New England Journal of Medicine could increase pressure on the Food and Drug Administration to restrict the sale of abortion pills associated with four fatal infections in California.
The FDA in September 2000 approved Mifeprex - also called RU-486 and known generically as mifepristone. It is used with a second drug, misoprostol, to induce early-stage abortions.
But as early as 1992, scientists warned mifepristone could make women vulnerable to massive bacterial infections. Some doctors have routinely defied FDA recommendations by advising women to administer misoprostol vaginally. Some researchers say that could transport bacteria near the uterus, where they can grow unchecked.
Thursday's article says four young, otherwise healthy women in California died from such bacterial infections soon after using RU-486 and misoprostol.
Conservative politicians and abortion foes have already been pressuring the FDA to take RU-486 off the market. The agency said it will convene a meeting to attempt to determine if there is a connection between the abortion pill and the fatal infections.
A Canadian woman also died from the infection. The deaths, out of about 510,000 medical abortions involving RU-486, while rare, amount to a roughly 1 in 100,000 risk of developing a fatal bacterial infection. That compares with a 0.1 in 100,000 risk for women who undergo surgical abortions performed at the same stage of pregnancy, according to the Journal article.
Danco Laboratories, which manufactures Mifeprex, said the fatal infections were not caused by its drug. Nor does vaginal administration of misoprostol increase the risk of infection, said Cynthia Summers, a Danco spokeswoman.
Days after using Mifeprex and misoprostol, the women complained of abdominal pain and vomiting. Without the typical warning sign of fever, a rare bacteria - Clostridium sordellii - multiplied inside their bodies, pumping out toxins. Within hours of seeking medical treatment, the women were dead.
A team of medical sleuths who investigate unexplained deaths studied clues from the women's tissues - in one case, performing an autopsy after a woman had been embalmed - according to Thursday's Journal.
"I think, for women, the take-home message just is that this is a now known, rare complication with this medication and they should be aware of that," Dr. Marc Fischer, a Centers for Disease Control researcher who was lead author of the article.
When the FDA approved Mifeprex, it did so with its strongest label warning.
The label has since been updated to include information about other serious complications.
In the Journal article, 13 federal and state investigators described a cluster of symptoms that physicians should watch for - including elevated heart rate, markedly elevated white blood cell counts, higher-than-normal red blood counts and eventual development of low blood pressure.
These deaths have important implications both for the care of individual patients and for public policy," said Dr. Michael F. Greene, obstetrics director at Massachusetts General Hospital, in an editorial in Thursday's Journal.
"Regulators should keep this rare complication in perspective and not overreact to scant data by prematurely foreclosing the only approved medical option for pregnancy termination," wrote Greene, an obstetrics, gynecology and reproductive biology professor at Harvard Medical School and occasional federal adviser.
The FDA has faced a growing number of critics who say the agency bungled oversight of antidepressants and safety problems posed by Bextra and Vioxx, painkillers that ultimately were pulled from the market. More recently, Democratic leaders accused the FDA of putting politics above science regarding the emergency contraception known as Plan B. The agency has yet to decide whether women can buy the morning-after pill without a prescription.
"Obviously, they're sort of running scared after the whole Vioxx thing and other high-profile withdrawals where they've been accused of being slow to respond - or responding inadequately to an apparent threat to the public health," Greene said.
But a leading French ethicist, who said his daughter was one of the women who died in California, wonders whether the FDA could better help doctors and patients. The man's daughter, a 34-year-old mother of two, died five days after her medical abortion, according to a letter published in the December issue of The Annals of Pharmacotherapy. Her earliest symptoms - abdominal pain and bleeding - appeared to be typical side effects from such abortions.
"Lack of awareness of the severity of the situation at this moment is dangerous," wrote Didier Sicard, the deceased woman's father, and Dr. Laurence Chauvelot-Moachon, of Hospital Cochin in Paris.
It may be "useful" to give women who undergo medical abortions antibiotics that work against C. sordellii before, during, and after taking the pills, they wrote.
The FDA has not recommended such preventive antibiotic use.
An American microbiologist who first linked tampons to fatal toxic shock syndrome said vaginal administration of misoprostol should be prohibited because it can increase infection risk.
"That may, in and of itself, eliminate the problem," said Philip M.
Tierno, director of clinical microbiology and immunology at New York University Medical Center.
An FDA spokeswoman said the safety and effectiveness of misoprostol administered vaginally "have not been established."
Diedtra Henderson can be reached at dhendersonglobe.com